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Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed HAART

NCT ID: NCT02322827

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

445 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-10-31

Brief Summary

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This study is designed to see how HIV infected patients perform when taking a single fixed dose HIV medication compared to a regimen with multiple tablets. The study is also going to be looking at the differences in complications between the two groups.

Detailed Description

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This is a phase IV retrospective chart review of HIV infected patients in a private Infectious disease practice in West Palm Beach, FL. This chart review will assign patients into one of two groups based on their antiretroviral regimen: single tablet regimen (STR) versus multi tablet regimen (MTR). Up to 650 patient charts will be reviewed but only about 500 patients are needed for statistical analysis.

The primary objective is to look at the proportion of patients with an adherence rate greater than or equal to 95% in subjects prescribed STR versus a MTR.

Secondary Objectives:

* Differences in emergency room visits, hospitalization and readmission in patients taking a STR vs. a MTR
* Proportion of patients with HIV viral load less than 50copies/microliter
* Incidence of new onset or worsening hyperlipidemia in patients taking a STR versus a MTR
* Incidence of acute renal insufficiency
* Compare the absolute CD4 number increase between a STR and a MTR
* Compare monthly copay amounts in patients taking a STR versus a MTR
* Identify the incidence of opportunistic infections in patients taking a STR versus a MTR

Conditions

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Acquired Immunodeficiency Syndrome Human Immunodeficiency Virus Type

Keywords

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hiv/aids

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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single tablet regimen

Subjects whose most recent antiretroviral therapy consist of a single tablet regimen

No interventions assigned to this group

multiple tablet regimen

Subjects whose most recent antiretroviral therapy consist of multi tablet regimen

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or Female (gender at birth), age 18 years or older
* Documented HIV-1 infection by western blot or HIV viral load
* Prescribed antiretroviral therapy, either STR (single tablet regime) or MTR (multi tablet regimen) for at least 6 months
* Patients should have a minimum of 3 office visits

Exclusion Criteria

* Patients who were evaluated in the hospital but never came to the clinic
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olayemi Osiyemi MD

OTHER

Sponsor Role lead

Responsible Party

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Olayemi Osiyemi MD

President

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Olayemi Osiyemi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Triple O Research Institute PA

Locations

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Triple O Research Institute PA

West Palm Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IN-US-236-1642

Identifier Type: -

Identifier Source: org_study_id